Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Reason for recall: Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. Distribution: US Nationwide distribution. OUS distribution pending. Quantity: 49,654 kits total Lot/code info: DYNJ64161C UDI-DI 10198459146961 Lot 25KBH332 DYNJ47103D UDI-DI 10198459625008 Lot 25LMF684 DYNJ67197G UDI-DI 10198459481994 Lot 25JBA258 DYNJ85197A UDI-DI 10198459217395 Lot 25LMF727 DYNJT4007 UDI-DI 10198459381867 Lot 26BBC180 DYNJ36698B UDI-DI 10198459081811 Lots 25KBM204 26CBD413 DYNJ89037 UDI-DI 10198459229855 Lots 25KBI083 25KBM202 DYNJ0171446I UDI-DI 10195327589516 Lot 25JBT239 DYNJ0171446J UDI-DI 10198459591754 Lot 26CBB295 DYNJ910915A UDI-DI 10198459424960 Lot 25LBD596 DYNJ87587A UDI-DI 10198459114199 Lot 25JBR735 DYNJ84482C UDI-DI 10198459362491 Lot 26BBU043 DYNJ49172I UDI-DI 10198459042003 Lot 26AMA388 DYNJ48013L UDI-DI 10198459560941 Lot 25LBP624 DYNJ0220136S UDI-DI 10198459566073 Lot 25LMF648 DYNJ908135B UDI-DI 10198459586552 Lots 25LBC200 25LBR878 DYNJ53044G UDI-DI 10198459448768 Lot 25LMG369 DYNJ909099F UDI-DI 10198459375996 Lot 25JMF136 DYNJ61711C UDI-DI 10198459096754 Lot 25JBT124 DYNJ20010L UDI-DI 10198459229053 Lot 25JMD853 DYNJ64964J UDI-DI 10198459254109 Lot 25LMI867 DYNJ43210K UDI-DI 10198459546792 Lot 25LMI070 DYNJ61787F UDI-DI 10198459169694 Lot 25JBU635 DYNJ87065 UDI-DI 10198459007439 Lots 25KBD819 25LBP631 DYNJ82564A UDI-DI 10198459497551 Lot 25LBD560 DYNJ54720D UDI-DI 10195327549510 Lot 26CBC228 DYNJ54722F UDI-DI 10195327549633 Lots 25KBB967 25LBQ696 26CBE680 DYNJ83095B UDI-DI 10198459562068 Lot 25JMD325 DYNJ32934F UDI-DI 10195327697181 Lot 26CBC762 DYNJ68935B UDI-DI 10198459440373 Lot 25LBN254 DYNJ66502B UDI-DI 10198459395321 Lot 25KBC481 DYNJ66252
10198459146961, 10198459625008, 10198459481994, 10198459217395, 10198459381867, 10198459081811, 10198459229855, 10195327589516, 10198459591754, 10198459424960, 10198459114199, 10198459362491, 10198459042003, 10198459560941, 10198459566073, 10198459586552, 10198459448768, 10198459375996, 10198459096754, 10198459229053, 10198459254109, 10198459546792, 10198459169694, 10198459007439, 10198459497551, 10195327549510, 10195327549633, 10198459562068, 10195327697181, 10198459440373, 10198459395321, 10198459185397, 10198459702358, 10195327579661, 10198459591990, 10198459143328, 10198459427985, 10198459366413, 10198459421556, 10198459526107
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.